FDA warns public vs eye drops
Photo from fda.gov.ph
MANILA, Philippines—The Food and Drug Administration (FDA) on Friday warned the public against the use of Power Drops, an unregistered product claiming to be a good remedy for a wide range of eye, ear and mouth ailments.
FDA Advisory No. 2014-53A said the product, manufactured by Living Power International Corp., was being promoted and distributed as “good for cataract, glaucoma, red eyes, teary eyes, pterygium, myopia, presbyopia, nasal polyps, runny nose, ear infection, oral thrush, toothache and tooth decay” without FDA registration.
The agency said the manufacturer carried a license only as a “food distributor/importer/exporter/wholesaler” and not as a drug distributor.
It also noted that the product’s label also carried the statement for food supplements, “No approved therapeutic claims,” even if it was classified as a drug.
Using the unregistered product may expose the public to safety risks and adverse health consequences, the FDA warned.
“Special solutions intended to treat eye and ear problems require special consideration in its manufacturing, storage and application,” it stressed.
It further explained that FDA registration and evaluation procedures ensured that all drug products complied with safety, efficacy and quality standards, and that these products were manufactured under the strict requirements of the Code of Good Manufacturing Practice.
“All consumers are advised to purchase and use only FDA-registered health products in FDA-licensed establishment, and to look for the FDA registration number or DR number when drug products are concerned,” it said.
The FDA also urged the public to report continuous sales or distribution of unregistered health products through e-mail at [email protected] or telephone number (02)8078275.
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